Study of Valproate in Young Patients Suffering From Epilepsy
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of
valproate administered as microgranules, under standard prescription conditions, with
therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations
and antiepileptic comedication as well as biological assays.
Secondary objectives: Ancillary population kinetics study
- Estimate the pharmacokinetic parameters of valproate administered as microgranules under
standard therapeutic conditions within the population studied, from the therapeutic
follow-up data.
- Evaluate the influence of individual characteristics on the pharmacokinetic parameters.
- Describe the relationship between plasma concentrations and adverse events for valproate
and the main anti-epileptic comedications.